Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione

EC Number:

700-064-6

Cas Number:

2105830-60-0

Molecular formula:

Not applicable as this is a UVCB substance

IUPAC Name:

Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione

Sampling and analysis

Analytical monitoring:

no

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Basis for effect:

mobility

Remarks on result:

other: Not toxic at loadings significantly above the solubility limit

Any other information on results incl. tables

Acute Toxicity Study in Daphnia magna with the Substance.

The study procedures described in this report were based on the OECD guideline No. 202, 2004. In addition, the procedures were designed to meet the test methods of the EEC directive 92/69, Part C.2, 1992, the ISO International Standard 6341, 1996 and the OECD series on testing and assessment number 23, 2000.

The batch of the Substance tested was a very viscous amber liquid and not completely soluble in test medium at the loading rate tested. Preparation of the test solution started with a 1: 1 stock in acetone. 260 µl (-200 mg) of this stock was added to 1 litre of ISO medium resulting in a nominal concentration of 100 mg/l. After a 3-day stirring period and a 10-minute stabilisation period, the aqueous mixture (containing test substance particles) was filtered through a membrane filter (0.45 µm). The clear and colourless filtrate was used for testing.

A limit test was performed, exposing twenty daphnids per concentration (four replicates, with five daphnids each) to the filtered solution and to a control. The total test period was 48 hours.

The project did not include sampling for determination of actual exposure concentrations. The study met the acceptability criteria prescribed by the protocol and was considered valid. The Substance did not induce acute immobilisation of Daphnia magna in a filtered solution prepared at a loading rate of 100 mg/l after 48 hours of exposure (NOEC). Hence, the 48h-EC50 was beyond the maximum soluble concentration.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the present study the Substance did not induce acute immobilisation of Daphnia magna in a filtered solution prepared at a loading rate of 100 mg/l after 48 hours of exposure (NOEC). Hence, the 48h-EC50 was beyond the maximum soluble concentration.

Executive summary:

SUMMARY

Acute Toxicity Study in Daphnia magna with the Substance.

The study procedures described in this report were based on the OECD guideline No. 202, 2004. In addition, the procedures were designed to meet the test methods of the EEC directive 92/69, Part C.2, 1992, the ISO International Standard 6341, 1996 and the OECD series on

testing and assessment number 23, 2000. The batch of the Substance tested was a very viscous amber liquid and not completely soluble in test medium at the loading rate tested. Preparation of the test solution started with a 1: 1 stock in acetone. 260 µl (-200 mg) of this stock was added to 1 litre of ISO medium resulting in a nominal concentration of 100 mg/l. After a 3-day stirring period and a 10-minute stabilisation period, the aqueous mixture (containing test substance particles) was filtered through a membrane filter (0.45 µm). The clear and colourless

filtrate was used for testing. A limit test was performed, exposing twenty daphnids per concentration (four replicates, with five daphnids each) to the filtered solution and to a control. The total test period was 48 hours. The project did not include sampling for determination of actual exposure concentrations. The study met the acceptability criteria prescribed by the protocol and was considered valid. the Substance did not induce acute immobilisation of Daphnia magna in a filtered solution prepared at a loading rate of 100 mg/l after 48 hours of exposure (NOEC). Hence, the 48h-EC50 was beyond the maximum soluble concentration.